跳至主要内容
临床试验/NCT05127239
NCT05127239已完成不适用

Constructing a Care Model Combing Smartphone Application to Improve Obstructive Apnea in Obesity Adults: a Longitudinal Study

Chang Gung University of Science and Technology2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2020年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
2
主要终点
Apnea-Hypopnea Index

研究概览

简要总结

A two-year study design is formulated. The overall aim of this study is to examine the effectiveness of the care model combing smartphone application on improve obstructive apnea in obesity adults.

详细描述

This study was the second year.The purpose of this study is to evaluate the effectiveness of the lifestyle modification intervention for overweight employees with obstructive sleep apnea. A randomized control trial with single blind will be used. Stratified with proportional randomized sampling will be employed and 160 suitable participants will be recruited from 4 electronics industries in northern of Taiwan. The subjects will be randomly divided into three groups. The total duration of intervention program is 6 months. Only the intervention group received the Combining Smartphone Application with lifestyle modification Intervention. The home portable sleep monitor will be used to collect the change of AHI at baseline, 3, and 6 months after intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

The research assistant who assisted in the production of serial numbers was not involved in recruitment, intervention, or data collection. In addition, the researcher who performed the data analysis did not participate in recruitment, intervention or data collection.

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a) >21 years old; b) )BMI greater than24 kg/m2; (c) the absence of any mental disorder, alcohol and drug addiction, and serious disease, such as cancer or cardiorespiratory failure; and d) Screening for OSA , AHI>5 and voluntary participation.

排除标准

  • a) diagnosis of OSA and currently under treatment and;b) diagnosis of severe depression (c) have cardiopulmonary diseases and are not suitable for activities; and d) plan to become pregnant during or within 6 months

结局指标

主要结局

Apnea-Hypopnea Index

时间窗: one night

using the Portable sleep monitor to examine the change of Apnea-Hypopnea Index

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsu Hsiu-Chin

Associate professor

Chang Gung University of Science and Technology

研究点 (2)

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